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Completed

NCT Number: NCT00680849

Enhancing Support for Women With Type 2 Diabetes: Follow-Up

This study is a 5-year continuation of "The Mediterranean Lifestyle Program." The purpose of this follow-up study is to determine the long-term effects from prior participation in an intervention promoting healthful eating, exercise, quitting smoking, stress management, and social support. Participants are post-menopausal women with type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiovascular Diseases Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Oregon Research Institute

Eugene, Oregon, 97403, United States

About this study

Coronary heart disease (CHD) is the leading cause of death and functional limitations among women in the U.S. Postmenopausal women with diabetes are at especially high risk of CHD, but CHD research with this population is very limited. This project addresses the poorly understood "natural history" of long-term maintenance of change in multiple behaviors (i.e., dietary, physical activity, social support, smoking cessation, and stress management) related to CHD risk, as well as the effects of theoretically important mediating variables on relapse and maintenance. The study is a continuation of a research project that has already demonstrated significant and consistent positive effects of a lifestyle change intervention on reduction of behavioral CHD risk factors. This research relies on a framework that synthesizes social-cognitive, social-ecologic, and goal-systems theories.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All participants in the original study are eligible. The inclusion criteria for the original study were:

  • diagnosis of type 2 diabetes for at least 6 months
  • being post-menopausal
  • living independently (e.g., not in an institution or nursing home)
  • having a telephone
  • ability to read English
  • not being developmentally disabled, and
  • living within 30 miles of the Eugene-Springfield metropolitan area.

Exclusion criteria

Exclusion criteria for the original study included:

  • being older than 75 years of age
  • having life-threatening illnesses, or
  • planning to move from the local area within the time span of the study.

Treatment and study plan

Primary outcomes

  1. Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues

    Time frame: annually, 36 months - 84 months

Secondary outcomes

  1. Lipids, weight loss

    Time frame: annually, 36 months - 84 months

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
May 20, 2008
Registry last updated
Oct 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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